Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

Cognitive Impairment Clinical Trial

Official title:

Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351540
• Other study ID #: IRB00332797
• Secondary ID: R21DA056687
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Dustin C Lee, PhD
• Phone: 410-550-4035
• Email: dlee214[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria: Healthy non-treatment seeking adults (age 18 to 60, N = 40) who report
• (a) infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline, or
• (b) report frequent cannabis use defined as > 5 days per week for > 1 year with a positive THC urine toxicology at baseline. These criteria were selected to target individuals with low and high-frequency cannabis use in order to examine the direct effect of tolerance on study outcome measures.

Exclusion Criteria:

• (1) meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine,
• (2) are currently receiving or interested in immediately receiving behavioral treatment or medication for cannabis cessation,
• (3) current use of any medications that could affect study outcomes,
• (4) test positive for drugs of abuse (other than cannabis) and/or breath alcohol test at study admission,
• (5) have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity,
• (6) are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding,
• (7) have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina), or (8) are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Related Conditions & MeSH terms

• Cannabis Use
• Cognitive Dysfunction
• Cognitive Impairment
• Impaired Driving
• Marijuana Abuse

Intervention

Drug:
• Cannabis
cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization

Locations

Country	Name	City	State
United States	Johns Hopkins Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Commission Errors	The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Commission errors is measured by calculating the number of trials participants incorrectly push the spacebar in the presence of "X" stimulus.	pre-administration, post-administration, 2, 4 hours
Primary	Omission Errors	The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Omission errors is measured by calculating the number of trials participants fail to push the spacebar in the presence of a letter that is not an "X" stimulus.	pre-administration, post-administration, 2, 4 hours
Primary	Reaction Time	The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time is measured by calculating the duration between the presentation of a letter other than "X", and the correct response of a spacebar push.	pre-administration, post-administration, 2, 4 hours
Primary	Reaction Time Standard Error	The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time standard error is measured by calculating the standard error of the mean of the reaction time.	pre-administration, post-administration, 2, 4 hours
Primary	Visuomotor Index	The visuomotor index score is calculated by mathematically integrating five measures of oculomotor fixation performance and two measures of accuracy into a single score during fixation and accuracy tasks, respectively. Test of visual fixation to measure microsaccades, spontaneous nystagmus, and gaze-evoked nystagmus.	pre-administration, post-administration, 2, 4 hours
Secondary	Saccade Speed	Measures how quickly participants look back and forth between two spots as possible during the oculomotor task.	Pre-administration, post-administration, 2, 4 hours
Secondary	Visually Guided Oculomotor Performance	Measures how quickly and accurately participants move their eyes to a cue as soon as it appears on the oculomotor task.	Pre-administration, post-administration, 2, 4 hours
Secondary	Antisaccade	Measures voluntary eye movement in the direction opposite to the side in which a visual cue is presented.	Pre-administration, post-administration, 2, 4 hours
Secondary	Memory-Guided	Measures how quickly gaze is shifted directly and accurately to a remembered cue position.	Pre-administration, post-administration, 2, 4 hours